A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)

Merck Sharp & Dohme LLC338 enrolled

Overview

This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

338

Conditions

Pneumococcal Infections

Interventions

V114 Medium DoseBIOLOGICAL

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose

V114 High DoseBIOLOGICAL

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose

V114 Medium Dose with Alternative Carrier ProteinBIOLOGICAL

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Adult Cohort: 18 to 49 years and in good health * Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine. Infant Cohort: approximately 2 months (42 to 90 days) and in good health. Exclusion Criteria: Adult cohort: Prior administration of any pneumococcal vaccine * History of invasive pneumococcal disease * Known hypersensitivity to any vaccine component * Known or suspected impairment of immune function * Coagulation disorder contraindicating intramuscular vaccination * Received a blood transfusion or blood products within 6 months * Participated in another clinical study of an investigational product within 2 months * Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine * Known hypersensitivity to any vaccine component * Known or suspected impairment of immune function * History of congenital or acquired immunodeficiency * Has or mother has documented Human Immunodeficiency virus (HIV) infection * Has or mother has documented hepatitis B surface antigen positive result * Functional or anatomic asplenia * History of failure to thrive * Coagulation disorder contraindicating intramuscular vaccination * History of autoimmune disease or autoimmune disorder * Known neurologic or cognitive behavioral disorder * Received systemic corticosteroids within 14 days * Received other licensed non-live vaccine within 14 days * Received other licensed live virus vaccine within 30 days * Received a blood transfusion or blood products * Participated in another clinical study of an investigational product * History of invasive pneumococcal disease

Outcomes

Primary Outcomes

Adults: Percentage of Participants With an Adverse Event

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Time frame: Up to 6 weeks after vaccination

Infants: Percentage of Participants With an Adverse Event

An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Time frame: Up to 1 month after Vaccination 4 (Month 11-15)

Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event

Time frame: Up to time of Vaccination 4 (Month 10-13)

Data from ClinicalTrials.gov

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